MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER

Model Number	FMS 2000
Medical Device Problem Codes	Increase in Pressure (1491); Failure to Infuse (2340)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Belmont medical technologies received the fda medwatch report (b)(4) on november 2, 2020.It was reported that during a code red trauma the belmont, fms (fluid management system) alarmed high pressure and stopped every few seconds and did not infuse the blood to the patient.We have contacted the customer to obtain further information regarding the disposables used as well as the device back in order to determine if there were any anomalies with the device.At this time we have not received the device from the hospital.A review of the device history records and service reports for the device indicate that the device has not been at our facility since it was shipped to the customer in 2013.Without the benefit of the device back at our facility for further investigation we note the following: as noted in the manual, when the fms detects a situation that may compromise safe and effective infusing, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.In the event of a "high pressure" alarm, the operator's manual also provides possible conditions and additional recommended operator actions.The rapid infuser may exhibit a "high pressure" alarm for the following reasons: 1) the patient line is blocked; 2) the recirculate line is blocked; 3) the infusion site is not well placed; 4) the catheter bore size is too small; or 5) the pressure limit setting is too low.In order to keep pressure in the line below the pressure limit, the system will reduce the infusion rate which may cause the flow rate to slow down or prevent it from reaching the set rate.In the event that the flow rate is slowing down or will not go at the set rate, the operator's manual provides the following recommended operator actions: 1) "check and remove kinks or obstructions in the tubing"; 2) "use the appropriate infusion set recommended in the guide, match the infusion set to flow rate and fluid type"; and 3) "increase flow by increasing the pressure limit.Change the pressure limit in calibration/setup to a higher limit (maximum pressure limit is 300 mmhg)".As high pressure may occur if the infusion site is not well placed or the catheter bore size is too small, the operator's manual instructs the user: "select an appropriate cannula size for the decided flow rate" and provides a chart to help the user choose an appropriate cannula size for the desired flow rate and infusate.Belmont clinical educators and technical support have reached out multiple times to the user facility to obtain additional details about the case.If and when additional information becomes available, a supplemental report will be provided.
Event or Problem Description
Belmont received a medwatch report (uf/importer report # (b)(4)) from the department of health & human services, about an event that reportedly occurred on (b)(4) 2020: "during a code red trauma, mass transfusion was ordered on the patient.The belmont rapid infuser malfunctioned and did not infuse blood as needed for the patient's care efforts.Instead, the belmont rapid infuser would only alarm high pressure and stop every few seconds.".

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 10805231
• Report Number: 1219702-2020-00093
• Device Sequence Number: 3814681
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K091855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FMS 2000
• Device Catalogue Number: 903-00001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1